An observational study in Aortic Valve Stenosis, sponsored by University of Luebeck. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-03.
Sponsored by University of Luebeck · Observational
Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →University of Luebeck is the lead sponsor of 74 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients who were treated with Myval TAVR via TAX access are included in the registry.
The participating centers also provide a retrospective cohort of TAX-TAVR implantations with other TAVR prothesis (e.g. Edwards Sapien XT/3/Ultra, Medtronic Evolut R/Pro, Accurate Neo, Allegra, Portico) to compare the results and outcomes of the MYVAL-TAX-TAVR registry using the Myval THV with other TAVR bioprothesis used for TAX-TAVR. To further improve comparability between groups propensity score matching between the groups will be performed using the following parameters (age, sex, STS score, peripheral artery disease, atrial fibrillation, minimum axillary diameter, moderate/severe axillary tortuosity and moderate/severe axillary, calcification).
Exclusion Criteria:
Study goal is to determine the feasibility, procedural success, safety and potential benefit of the Myval transcatheter heart valve (THV) in patients undergone transaxillary (TAX) transcatheter aortic valve replacement (TAVR).
Time until first occurrence
* Stroke including ischemic or hemorrhagic stroke, * Systemic embolism, * Major bleeding (BARC type 3-5), or Cardiovascular or unexplained death
Time frame: 30 Days
Plan to share: No
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University of Luebeck